Breathing & Blood Pressure

Healthy Clinical Trial

Official title:

Breathing & Blood Pressure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05632406
• Other study ID #: STUDY00003469
• Status: Recruiting
• Start date: October 25, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: November 2023
• Source: Florida State University
• Contact: Joseph Watso, PhD
• Phone: 850-644-5260
• Email: jwatso[@]fsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the effect of obesity on cardiovascular responses during various breathing maneuvers.

Description:

Adults with higher body mass can have trouble breathing during exercise, which could be due to high respiratory muscle workloads. These breathing muscles can require a lot of energy, which takes away energy from other (e.g., leg) muscles. Participating in this study will help us understand how the heart and blood vessels respond during brief exercise and during various breathing maneuvers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Body mass index values of =40 kg/m^2

Exclusion Criteria:

• Not weight stable (<5% change in body mass over the past six months)

• Overt cardiovascular, neurological, renal, liver, and/or metabolic illness (e.g., diabetes mellitus)

• Current, or history of uncontrolled, Stage 2 hypertension (blood pressure >140 / 90 mmHg; anti-hypertensive medications are permitted)

• Diagnosed obstructive sleep apnea

• Previous bariatric surgery

• Diagnosis or signs (e.g., values below the lower limit of normal) of overt airway disease(s)

• Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes, vaping)

• Per the POWERbreathe® company:

• Patients who have undergone recent abdominal surgery and those with abdominal hernia.

• Asthma patients who have a very low symptom perception and suffer from frequent, severe exacerbations or with an abnormally low perception of dyspnoea.

• If a patient is suffering from a ruptured eardrum or any other condition of the ear.

• Patients with marked elevated left ventricular end-diastolic volume and pressure.

• Patients with worsening heart failure signs and symptoms after a respiratory/inspiratory muscle training (IMT) session

• If you are suffering from a cold, sinusitis, or respiratory tract infection, we advise that you do not use your POWERbreathe IMT device.

• Individuals who are not yet adults (infants, children, teenagers)

• Pregnant (self-reported and urine pregnancy test conducted), lactating (self-reported), or post-menopausal (self-reported) females

• Prisoners

Related Conditions & MeSH terms

• Healthy
• Overweight
• Overweight and Obesity

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure during exercise	Systolic and diastolic blood pressure measured in the laboratory at rest and during an incremental aerobic exercise test	Up to one week
Secondary	Blood pressure during respiratory muscle testing	Systolic and diastolic blood pressure measured in the laboratory at rest and during a respiratory muscle exercise test (eucapnic voluntary hyperpnea)	Up to one week

External Links

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